- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07408947
Clinical Severity in Scorpion Envenomation: Home Remedies, Delay to Medical Care, and Antivenom Dosing Strategies in an Emergency Department
Clinical Severity in Scorpion Envenomation: Home Remedies, Delay to Medical Care, and Antivenom Dosing Strategies in an Emergency Department in Jalisco, Mexico
Scorpion stings are a common medical emergency in Mexico, particularly in the state of Jalisco. While antivenom is the standard treatment for scorpion envenomation, there is variability in how it is used, including differences in dosing strategies. In addition, many patients use home remedies before seeking medical care, which may delay treatment and influence the severity of symptoms.
This study is an observational, retrospective analysis of patients treated for scorpion envenomation in the emergency department of a public hospital in Jalisco, Mexico, between 2021 and 2023. Using information from medical records, the study examines the relationship between the use of home remedies, the time to receive medical care, clinical severity at presentation, and the antivenom dosing strategies used, including traditional and reduced-dose approaches.
The goal of this study is to better understand factors associated with clinical severity and antivenom use in real-world emergency care. The results may help inform future clinical decision-making, promote rational use of antivenom, and improve timely access to appropriate medical treatment for patients with scorpion envenomation.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Jalisco
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Guadalajara, Jalisco, Mexico, 44340
- Centro Universitario de Ciencias de la Salud
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients of any age with a clinical diagnosis of scorpion envenomation.
- Patients evaluated and treated in the emergency department of the participating hospital.
- Availability of medical records with sufficient clinical information to assess envenomation severity, time to medical care, and antivenom administration.
Exclusion Criteria:
- Patients with incomplete or missing medical records that do not allow determination of clinical severity or antivenom use.
- Patients transferred from another healthcare facility after having already received definitive treatment for scorpion envenomation.
- Patients with documented co-envenomation or alternative diagnoses that could confound clinical severity assessment.
- Patients who declined medical evaluation or left the emergency department before completion of initial assessment and management.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Reduced dose
This group includes patients diagnosed with scorpion envenomation who were managed using a reduced-dose antivenom strategy during routine emergency care. In this approach, antivenom (faboterápico) was administered primarily to patients with systemic manifestations of envenomation. The initial dose generally consisted of a single intravenous vial, with additional vials administered only if clinical symptoms persisted or progressed after reassessment. Patients who did not receive antivenom because they presented without systemic symptoms were also included in this group. This management strategy differs from the Mexican national Clinical Practice Guidelines, which recommend antivenom administration to all patients with scorpion envenomation, regardless of the presence or absence of systemic symptoms. All treatment decisions were made by the treating physicians as part of standard clinical care, without protocol-mandated interventions. |
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Traditional dose
This group includes patients diagnosed with scorpion envenomation who were managed according to the traditional antivenom dosing strategy recommended by the Mexican national Clinical Practice Guidelines. These guidelines advise administering antivenom (faboterápico) to all patients with scorpion envenomation, independent of whether systemic symptoms are present, with dosing adjusted based on patient age and clinical severity. Under this strategy, patients typically received one or more intravenous vials of antivenom as an initial dose, with additional doses administered at predefined intervals if symptoms persisted, in accordance with guideline-based algorithms. All treatments were provided as part of routine emergency care, and no interventions were assigned for research purposes. This group reflects standard-of-care antivenom use in Mexico during the study period. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Clinical resolution of symptoms within 3 hours
Time Frame: From emergency department admission to 3 hours after initial treatment.
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Proportion of patients with scorpion envenomation who achieved complete clinical resolution of signs and symptoms within three hours after initial medical management in the emergency department.
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From emergency department admission to 3 hours after initial treatment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Need for additional antivenom doses
Time Frame: From initial antivenom administration until emergency department discharge (up to 24 hours)
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Proportion of patients who required one or more additional doses of antivenom after the initial administration due to persistence or progression of clinical symptoms.
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From initial antivenom administration until emergency department discharge (up to 24 hours)
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Total number of antivenom vials administered
Time Frame: From initial antivenom administration until emergency department discharge (up to 24 hours)
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Total number of antivenom (faboterápico) vials administered per patient during emergency department management.
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From initial antivenom administration until emergency department discharge (up to 24 hours)
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Use of supportive medications
Time Frame: From initial antivenom administration until emergency department discharge (up to 24 hours)
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Use of additional supportive medications, including benzodiazepines, anticholinergics, opioids, antiemetics, or other agents, administered during emergency department management.
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From initial antivenom administration until emergency department discharge (up to 24 hours)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Clinical severity at presentation
Time Frame: At emergency department triage (baseline)
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Clinical severity of scorpion envenomation at the time of emergency department presentation, classified according to national clinical criteria (mild, moderate, or severe), based on documented signs and symptoms
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At emergency department triage (baseline)
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Use of home remedies prior to medical care
Time Frame: At emergency department triage (baseline)
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Proportion of patients who reported the use of home remedies (traditional treatments) prior to seeking medical care for scorpion envenomation, as documented in the medical record.
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At emergency department triage (baseline)
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Delay to medical care
Time Frame: From time of scorpion sting to recorded emergency department triage time (baseline)
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Time elapsed between scorpion sting and arrival at the emergency department.
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From time of scorpion sting to recorded emergency department triage time (baseline)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Christian J Baños, PhD, University of Guadalajara
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Epidemiología del alacranismo
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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